Cleared Traditional

K991615 - POLYURETHANE POWDER FREE DENTAL EXAMINA...

K991615 is an FDA 510(k) clearance for POLYURETHANE POWDER FREE DENTAL EXAMINA..., manufactured by Maxxim Medical. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K991615 · Maxxim Medical · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
81d
Days
Class 1
Risk

K991615 is an FDA 510(k) clearance for the POLYURETHANE POWDER FREE DENTAL EXAMINATION GLOVE, POLYURETHANE POWDER FREE M.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Maxxim Medical (Oldsmar, US). The FDA issued a Cleared decision on July 30, 1999 after a review of 81 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Maxxim Medical devices

FDA 510(k) Submission Details - K991615

510(k) Number K991615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1999
Decision Date July 30, 1999
Days to Decision 81 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 129d · This submission: 81d
Pathway characteristics
Predicate-based equivalence.

LZA Device Classification - Class 1, General Controls

Product Code LZA Polymer Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Nitrile (or Polymer) Patient Examination Glove Is A Disposable Device Made Of Nitrile Rubber Or Synthetic Polymers That May Or May Not Bear A Trace Amount Of Residual Powder, And Is Intended To Be Worn On The Hand For Medical Purposes To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LZA Polymer Patient Examination Glove

All 682
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K991615.
SAFESKIN POLYMER-COATED NITRILE EXAMINATION GLOVES, POWDER-FREE SHIELDMASTER NITRILE GLOVE
K992830 · Safeskin Corp. · Oct 1999
SHIELDMASTER POWDERED PURPLE NITRILE EXAMINATION GLOVES
K992210 · Safeskin Corp. · Sep 1999
SAFESKIN STERILE PURPLE NITRILE EXAMINATION GLOVES
K992062 · Safeskin Corp. · Aug 1999
BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDERED)
K990876 · Brightway Holdings Sdn. Bhd. · Jun 1999
POWDERED NITRILE EXAMINATION GLOVE, WHITE (NON-COLORED)
K991511 · Perusahaan Getah Asas Sdn. Bhd. · Jun 1999
BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDER FREE)
K990878 · Brightway Holdings Sdn. Bhd. · May 1999